NDC 48433-220 Docusate Sodium

Docusate Sodium

NDC Product Code 48433-220

NDC CODE: 48433-220

Proprietary Name: Docusate Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Docusate Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

NDC Code Structure

  • 48433 - Safecor Health, Llc

NDC 48433-220-10

Package Description: 10 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Docusate Sodium with NDC 48433-220 is a a human over the counter drug product labeled by Safecor Health, Llc. The generic name of Docusate Sodium is docusate sodium. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1245686.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Docusate Sodium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLOXAMER 181 (UNII: 09Y8E6164A)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Safecor Health, Llc
Labeler Code: 48433
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Docusate Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each 5 Ml = 1 Teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener

Use:

Relief of occasional constipation

Otc - Do Not Use

Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

Dosage & Administration

Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation* Shake well before using* Do not exceed recommended dose* May be taken in one to four equally divided oral doses each day* Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual responseAdults and children 12 years of age and over5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctorChildren 6 to 12 years of age4 mL to 15 mL (3 teaspoons) or as directed by a doctorChildren 3 to 6 years of age2 mL to 6 mL or as directed by a doctorChildren under 3 years of age1 mL to 4 mL or as directed by a doctor1 teaspoon = 5 mL

Other Safety Information

Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursionsbetween 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.

Inactive Ingredient

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purifiedwater, sodium benzoate, sodium citrate, and sucralose.NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose CupMfd. in the U.S.A.Distributed by: Safecor Health, LLC4060 Business Park Drive, Columbus, OH 43204                                                   Rev: 11/2020 PN54733 4843322010 8

* Please review the disclaimer below.